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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022009
Receipt No. R000025361
Scientific Title Effect of functional foods on bodily function
Date of disclosure of the study information 2017/02/01
Last modified on 2016/11/15

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Basic information
Public title Effect of functional foods on bodily function
Acronym Effect of functional foods on bodily function
Scientific Title Effect of functional foods on bodily function
Scientific Title:Acronym Effect of functional foods on bodily function
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The present study aimed to investigate whether physical and psychological condition, the autonomic nervous system and immunoglobulin A in the saliva and stool could change by functional foods in healthy subjects.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The sIgA level in saliva and stool
Key secondary outcomes Autonomic nerves activity level by heart rate variability.
Sympathetic nerves activity: low frequency(LF)/ high frequency(HF)
Sympathetic nerves activity: HF

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Placebo: dextrin(14days)
wash out(14days)
Active Hexose Correlated Compound: AHCC(14days)
Interventions/Control_2 Active Hexose Correlated Compound: AHCC(14days)
wash out(14days)
Placebo: dextrin(14days)

Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
16 years-old <=
Age-upper limit
30 years-old >
Gender Male and Female
Key inclusion criteria 1. Aged 16-29 years.
2. Person that informed consent was provided.
Key exclusion criteria 1. Person having a disease.
2. Person who takes medicine.
3. Current smokers
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Hisajima
Organization University of Teikyoheise Faculty of Health Care
Division name Department of acupuncture and Moxibustion.
Zip code
Address 2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo, Japan.
TEL 035-843-3111
Email hisajimatatsuya@mac.com

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Hisajima
Organization University of Teikyoheise Faculty of Health Care
Division name Department of acupuncture and Moxibustion.
Zip code
Address 2-51-4 Higashi-ikebukuro, Toshima-ku, Tokyo, Japan.
TEL 035-843-3111
Homepage URL
Email hisajimatatsuya@mac.com

Sponsor
Institute University of Teikyoheise Faculty of Health Care. Department of acupuncture and Moxibustion.
Institute
Department

Funding Source
Organization University of Teikyoheise
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 21 Day
Last follow-up date
2016 Year 06 Month 12 Day
Date of closure to data entry
2016 Year 07 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 21 Day
Last modified on
2016 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025361

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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